국내 정신약물 임상연구 현황과 데이터베이스 구축

Reviewing and Constructing Clinical Trials Database for Psychotropic Drugs in Korea

본 연구에서는 한국 정신과 관련 저널들에서 시행된 약물 관련 연구들의 특성을 살펴보고 그것들을 데이터베이스하는 작업을 시도하였다. 1995년에서 2010년까지 국내 발간된 정신과 저널 중에서 사람을 대상으로 한 임상약물실험연구에 대한 모든 원저들을 분석하였다. RCT, CCT, NCCT, NTN들을 분석대상으로 했으며 증례 보고는 제외했다. 전체 대상 임상연구수는 328편이었으며 이들 중 NCCT가 151편(46%), NTN이 78편(23.7%), RCT가 59편(17.9%), CCT가 36편(10.9%)이었다. 전체 기간 중 대한정신약물학회지가 130편(39.63%)으로 가장 많았고 EBM 근거 수준이 가장 높은 RCT 논문비율은 신경정신의학이 19.48%로 가장 많았다. 연구질환은 조현병이 158편(47.02%)로 가장 많았고, 주요우울장애 및 기타우울장애, 양극성 장애, 치매, 공황장애, 분열정동장애, 범불안장애 순이었다. 이전과 비교해 IRB승인을 받은 연구가 늘어났고, 외부연구비 지원을 받은 경우도 증가하였다. 향후 본 연구결과와 데이터베이스를 기반으로 국내 임상약물연구 데이터베이스를 보완, 구축해야 하며 논문의 질평가 작업도 함께 이루어져야 할 것이다.

Objective Evidence-based medicine (EBM) became an important framework to help clinicians judge and decide on what is better or desirable practice under National Insurance Scheme. Clinical trials contribute to building the data for EBM. We tried to investigate the characteristics of clinical trials which had been published in Korean psychiatry journals and constructed them as database form. Methods We reviewed all original articles about clinical drug trials regarding human in twenty Korean psychiatric journals published from 1995 to 2010. Inclusion criteria were randomized clinical trials (RCT), controlled clinical trials (CCT), non-controlled clinical trials (NCCT), non-trial naturalistic trials (NTN) including pharmacological intervention. Case reports and case series were excluded. Initial review and classification has been done by EBM researcher and expert review was followed by insurance committee members of Korean College of Neuropsychopharmacology. Results Total number of clinical trials was 328 and all the articles were classified according to patients subtype and intervention. Among them, NCCT was 151 (46%), NTN was 78 (23.7%), RCT was 59 (17.9%), and CCT was 36 (10.9%). In this study, the articles in The Korean Journal of Psychopharmacology were 130 (39.63%) and the proportion of RCT was the most in Journal of the Korean Neuropsychiatric Association (19.84%). The schizophrenia came with 158 (47.02%), followed by major depressive disorder and other depressive disorder, bipolar disorder, dementia, panic disorder, schizoaffective disorder, and generalized anxiety disorder. The proportion of Institutional Review Board approved study and study with research grant has increased. Conclusion In this study, we investigated the characteristics of clinical trials for psychotropic drugs and finished to construct clinical trial database for psychotropic drugs in Korea. We hope this database should be used for researchers who want to collect clinical evidence data and make clinical guidelines for Korean psychiatric patients. In future, supplementation and management of clinical trial database for psychotropic drugs and quality control of articles are needed.